A randomized trial comparing simultaneous vs. sequential field treatment of actinic keratosis with ingenol mebutate on two separate areas of the head and body. (24th August 2015)

• Record Type: Journal Article
• Authors: Pellacani, G.; Peris, K.; Guillen, C.; Clonier, F.; Larsson, T.; Venkata, R.; Puig, S.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 29:Number 11(2015:Nov.)
• Page Start: 2192
• Page End: 2198
• Publication Date: 2015-08-24
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.13211
• Languages: English
• ISSNs: 0926-9959

Abstract

<abstract abstract-type="main" id="jdv13211-abs-0001"> <title>Abstract</title> <sec id="jdv13211-sec-0001" sec-type="section"> <title>Background</title> <p>Actinic keratoses (AKs) are precursors to invasive squamous cell carcinoma and can progress if untreated. Limited data support the use of ingenol mebutate to treat AKs on more than one area of the body simultaneously.</p> </sec> <sec id="jdv13211-sec-0002" sec-type="section"> <title>Objective</title> <p>To investigate safety, efficacy and treatment satisfaction when treating separate areas simultaneously or sequentially with different concentrations of ingenol mebutate gel.</p> </sec> <sec id="jdv13211-sec-0003" sec-type="section"> <title>Methods</title> <p>In this phase IIIb study (NCT01787383), patients with clinically visible, non‐hyperkeratotic AKs on two separate treatment areas (face/scalp and trunk/extremities) were randomized to simultaneous or sequential treatment with ingenol mebutate gel (0.015% and 0.05%). Endpoints included composite local skin response (LSR) score 3 days after first application, complete AK clearance and percentage reduction in AKs at week 8.</p> </sec> <sec id="jdv13211-sec-0004" sec-type="section"> <title>Results</title> <p>There were no statistically significant differences between simultaneous (<italic>n</italic> = 101) and sequential (<italic>n</italic> = 98) groups in composite LSR score (10.4 vs. 9.7), complete clearance (52.7% vs. 46.9%) or percentage reduction in AKs (83.4% vs. 79.1%). Mean composite LSR scores on face/scalp and trunk/extremities were similar for both groups. Adverse event (AE) incidence was comparable between groups, the most common treatment‐related AEs being pruritus and pain at the application site.</p> </sec> <sec id="jdv13211-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Treating AKs with ingenol mebutate simultaneously or sequentially gave similar results in terms of tolerability (LSR score, AEs) and efficacy (complete clearance). Therefore, the physician and patient can select the most convenient treatment regimen, with confidence in achieving a similar outcome.</p> </sec> </abstract>